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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D

An Open-Label, First-in-Human Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With Type 1 Diabetes Mellitus (T1D)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open-label, multicenter, Phase 1/2 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of T1D for a minimum of 5 years - Stable diabetes regimen for at least 3 months prior to enrollment. Who Should NOT Join This Trial: - Medical history of islet cell, kidney, and/or pancreas transplant - Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment - Known causes of diabetes other than T1D - Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study - Prior treatment with gene therapy or edited product Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of T1D for a minimum of 5 years * Stable diabetes regimen for at least 3 months prior to enrollment. Exclusion Criteria: * Medical history of islet cell, kidney, and/or pancreas transplant * Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment * Known causes of diabetes other than T1D * Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study * Prior treatment with gene therapy or edited product

Treatments Being Tested

COMBINATION_PRODUCT

VCTX211

CRISPR-Cas9 genetically modified PEC211 cells loaded into a delivery device

Locations (2)

University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada